Principal Clinical Data Manager

About the role

Highly skilled and seasoned Principal Clinical Data Manager with extensive experience in the management and oversight of clinical data throughout the entire data lifecycle. Proven track record of successful leadership in designing, implementing, and managing data management strategies for complex clinical trials in adherence to industry standards and regulatory requirements. Strong leader effective in managing and fostering cross-functional collaboration among clinical operations, biostatistics, and programming teams to achieve seamless integration of data management activities to drive operational efficiencies and meet project timelines. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.

Accelerate your skills and career within a fast-paced, fast-growing company while impacting the future of healthcare.

Responsibilities

• Primary representative for eClinical Solutions and sponsor data management interaction; ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope
• Function as Data Management subject matter expert providing guidance on data management best practices, technology, and solutions
• Provide study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, and Query Management
• Define specifications and collaborate with technical team on configuration of elluminate® for data cleaning strategy and oversight activities
• Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables, and elluminate® modules
• Perform quality oversight and data trending via elluminate® reporting and analytics to identify risks and develop mitigation and data cleaning strategies
• Collaborate with technical and engineering teams on tech-enabled solutions in areas for process and efficiency improvement
• Collaborate with functional managers and training team to deliver training
• Other duties as assigned

Requirements

• Bachelor’s degree or higher (master’s in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline
• 10+ years’ experience in Pharmaceutical/Biotechnology industry with Clinical Data Management or equivalent consulting role
• CCDM Certification preferred
• Strong project management experience and project team leadership skills including work planning, work delegation, and solving complex problems; prefer experience with agile and six sigma methodologies
• Strong consulting and client relationship management skills
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning, and organization skills
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred)
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards

AI Use Statement

Employees are expected to appropriately leverage company-approved AI tools to improve productivity and quality while adhering to company policies, protecting confidential information, validating AI-generated content, and exercising sound professional judgment. AI is intended to augment—not replace—professional judgment, critical thinking, accountability, and decision-making. Accountability for all work remains with the employee.

Benefits

eClinical Solutions is a winner of the 2025 Top Workplaces USA Award for Remote Work and has received numerous Top Workplaces Culture Excellence Awards celebrating exceptional company vision, values, and work-life balance.

eClinical Solutions is a people-first organization with an inclusive culture that values diversity, individual experiences, and continuous learning and improvement.

Pay

US Pay Range: $125,000 - $145,000 USD